European Committee for Proprietary Medicinal Products Adopts Positive Option For Kaletra(TM) for the Treatment of HIV

18.12.2000 – 09:01

Abbott Park, Ill. (ots-PRNewswire) - Abbott Laboratories today
announced that the Committee for Proprietary Medicinal Products
(CPMP) in the European Union has adopted a positive opinion on
Kaletra(TM) (lopinavir/ritonavir), previously known as ABT-378/r.
Kaletra is an advanced-generation protease inhibitor (PI) indicated
for the treatment of HIV infection in adults and children above the
age of 2 years. The CPMP opinion will be considered by the European
Commission, which will make the final decision regarding marketing
authorization, a process that takes approximately 90 days.
"The positive opinion is a major step forward in bringing Kaletra
to patients in Europe," said David Goffredo, vice president, European
operations, Abbott Laboratories. "Clinical data demonstrates that
Kaletra provides effective, durable and tolerable therapy, and we
look forward to the opportunity to make Kaletra available to people
with HIV."
The CPMP positive opinion of Kaletra, which was granted under
exceptional circumstances, was based on results from a 24-week
controlled Phase III clinical trial and additional smaller Phase II
trials. For serious illnesses where patients need access to new
medications, the CPMP will adopt a positive opinion under exceptional
circumstances based on data from ongoing studies. Longer-term data
from these studies were presented at the recent Fifth International
Congress on Drug Therapy in HIV Infection in Glasgow, UK, on Oct.
22-25, 2000.
Kaletra's Long-Term Effectiveness as a First-Line PI
In a Phase III, double-blind, ongoing international clinical study
comparing two protease inhibitors, Kaletra was shown to be more
effective than nelfinavir, the most widely prescribed PI, at reducing
HIV viral levels after 48 weeks of treatment in patients new to HIV
therapy. A separate ongoing Phase II study of Kaletra in patients new
to HIV therapy showed that Kaletra provides durable, tolerable
therapy after more than two years (108 weeks) of treatment.
Lack of Resistance Development to Kaletra in Clinical Trials
An analysis of resistance data from three studies of Kaletra shows
that no genotypic resistance has been observed to date in more than
450 patients new to HIV therapy in clinical trials. This analysis
includes data from two 48-week studies and one study of more than two
years duration. Genotypic testing examines a viral sample for
specific mutations, or changes, in the virus that are known to cause
resistance to certain drugs. Viral resistance is one of the main
causes of viral rebound and subsequent treatment failure for people
with HIV.
Kaletra's Effectiveness in a Broad Spectrum of Patients
In addition to its demonstrated efficacy in patients new to HIV
therapy, Kaletra has provided effective viral suppression in a broad
spectrum of patients with HIV, including treatment-naive and
treatment-experienced adults and children. In an ongoing Phase II
pediatric trial in 100 children, Kaletra continued to provide
effective, tolerable treatment after nearly one year (48 weeks) of
therapy, with only two patient discontinuations. In addition, two
separate Phase II studies of Kaletra combined with non-nucleoside
reverse transcriptase inhibitors (NNRTIs) show good viral suppression
in patients who had previously been treated with one or more PIs.
The most commonly reported, Kaletra-related adverse events were
abdominal pain, abnormal stools, diarrhea, feeling weak or tired,
headache, nausea and vomiting.
Based on the urgent need for new treatment options, Abbott
initiated its Early Access Program prior to regulatory submission and
market authorization to provide Kaletra to HIV-positive patients who
do not have other viable treatment options. The program was designed
by working closely with key regulatory agencies and representatives
of several HIV treatment organizations and currently is available to
more than 13,000 patients in more than 30 countries worldwide,
including 19 countries in Europe. Abbott will continue to provide
Kaletra to patients in the countries participating in the program
until Kaletra is available with a prescription to ensure patients
will have continued, uninterrupted access to Kaletra.
Abbott Laboratories has been a leader in HIV/AIDS research since
the early years of the epidemic. In 1985, the company developed the
first licensed test to detect HIV antibodies in the blood, and
remains the leader in HIV diagnostics. Abbott retroviral and
hepatitis tests are used to screen more than half of the world's
donated blood supply. With Kaletra, Abbott has developed two protease
inhibitors, and also offers nutritional products that meet the unique
dietary needs of people living with HIV.
Abbott Laboratories is a global, diversified health care company
devoted to the discovery, development, manufacture and marketing of
pharmaceutical, diagnostic, nutritional and hospital products. The
company employs 60,000 people and markets its products in more than
130 countries. In 1999, the company's sales and net earnings were
$13.2 billion and $2.4 billion, respectively, with diluted earnings
per share of $1.57.
Abbott 's news releases and other information are available on the
company's Web site at www.abbott.com .
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